Quadcut® 1884380HR (UDI 20613994779186)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 20613994779186), received between Oct 30, 2018 and Aug 27, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Vibration” (13 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Vibration

  It was reported that during procedure device was found vibrating. The procedure was completed using another device. There was no patient impact

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50467016 ↗
• MalfunctionAug 24, 2026Break

  It was reported that blade was broken. There was no known patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50403995 ↗
• MalfunctionSep 11, 2025Vibration; Vibration

  IT WAS REPORTED THAT DURING SET UP THE BLADE WOBBLED WHEN ACTIVATED, SEEMS INSECURE WITH THE MICRODEBRIDER HANDLE. THE HANDPIECE WAS THE COMPONENT THAT WAS VIBRATING AND CAUSED THE BLADE TO WOBBLE. THE VIBRATING DEVICE WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER BLADE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23023658 ↗
• MalfunctionJun 10, 2025Vibration; Noise, Audible; Vibration; Noise, Audible

  IT WAS REPORTED THAT DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY FROM THE FIRST ACTIVATION OF THE STRAIGHT SHOT THERE WAS ABNORMAL SHAKING OF THE QUAD CUT BLADE AND IT WAS MAKING AN ODD SOUND. THE BLADE WAS REJECTED AND RESET IT INTO THE HAND PIECE, HOWEVER, THE PROBLEM WAS NOT RESOLVED. A NEW QUAD CUT BLADE WAS OPENED AND PLACED INTO THE SAME STRAIGHT SHOT AND NO ISSUES WERE OBSERVED. THE CASE WAS COMPLETED WITH THE BACKUP PRODUCT. THE PROCEDURE WAS EXTENDED UP TO 10 MINUTES. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22175618 ↗
• MalfunctionMay 20, 2025Break; Break

  IT WAS REPORTED THAT DURING A FESS CASES, THE BLADE WASN'T WORKING PROPERLY AND ULTIMATELY BROKE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE IS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22050921 ↗
• MalfunctionMar 17, 2025Vibration; Vibration

  IT WAS REPORTED THAT AFTER SET UP, THE M5 HANDPIECE HAD A CLICKING NOISE AND VIBRATING WHEN ACTIVE. THE HANDPIECE CAUSE THE BLADE TO VIBRATE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21617198 ↗
• MalfunctionFeb 24, 2025Break; Break

  IT WAS REPORTED THAT, DURING THE FUNCTIONAL ENDOSCOPIC SINUS SURGERY THE DOCTOR STARTED TO USE THE QUADCUT BLADE WITH MICRODEBRIDER M4 AND THE DOCTOR NOTICED THAT THE SHAVER WAS NOT WORKING. DOCTOR PULLED IT OUT OF NOSE. ON EXAMINATION, DOCTOR OBSERVED THAT THE BASE OF THE BLADE ABOUT 1CM FROM HUB WAS BROKEN INTO TWO PIECES, NEAR THE BASE OF MICRODEBRIDER. BLADE REPLACED FROM THE SAME LOT NUMBER AND PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445888 ↗
• MalfunctionJan 31, 2025Vibration; Vibration

  IT WAS REPORTED THAT, VERY EARLY IN THE PROCEDURE, WHEN THE SCRUB TECH LOADED THE BLADE INTO AN M4 AND NOTICED THE BLADE WOULD OSCILLATE BACK AND FOURTH/VIBRATE WHEN ACTIVATED. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21281051 ↗
• MalfunctionAug 23, 2024Vibration; Vibration

  IT WAS REPORTED THAT DURING PREPARATION, AFTER MOUNTING THE BLADE ON THE MICRODEBRIDER STRAINGHSHOT M5, TESTING THE OPERATION OF THE HANDPIECE THE HCP NOTICED THAT THE TERMINAL PART OF THE BLADE, DUE TO OSCILLATION OF THE MOTOR, VIBRATED CONSISTENLY. FIRSTLY THEY TRIED TO REINSERT THE BLADE (BUT WAS FIRMLY AND CORRECTLY MOUNTED), THEN TO CHANGE THE BLADE THINKING TO A DEFECTIVE PRODUCT BUT ALSO THE SECOND BLADE SHOWED THE SAME MOVEMENT. AFTER, THEY TRIED TO CHANGE THE HANDPIECE TO AVOID THAT THE ISSUE WAS CAUSED BY A MALFUNCTIONING DEBRIDER BUT THE PROBLEM OCCURRED ALSO WITH THE SECOND HANDPIECE. LASTLY THEY CHANGE THE BLADE USING ANOTHER PACK OF THE SAME MODEL AND EVERYTHING WORKED PROPERLY. THERE WAS NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20046739 ↗
• MalfunctionAug 23, 2024Vibration; Vibration

  IT WAS REPORTED THAT DURING PREPARATION, AFTER MOUNTING THE BLADE ON THE MICRODEBRIDER STRAIGHTSHOT M5, TESTING THE OPERATION OF THE HANDPIECE THE HCP NOTICED THAT THE TERMINAL PART OF THE BLADE, DUE TO OSCILLATION OF THE MOTOR, VIBRATED CONSISTENTLY. FIRSTLY THEY TRIED TO REINSERT THE BLADE (BUT WAS FIRMLY AND CORRECTLY MOUNTED), THEN TO CHANGE THE BLADE THINKING TO A DEFECTIVE PRODUCT BUT ALSO THE SECOND BLADE SHOWED THE SAME MOVEMENT. AFTER, THEY TRIED TO CHANGE THE HANDPIECE TO AVOID THAT THE ISSUE WAS CAUSED BY A MALFUNCTIONING DEBRIDER BUT THE PROBLEM OCCURRED ALSO WITH THE SECOND HANDPIECE. LASTLY THEY CHANGE THE BLADE USING ANOTHER PACK OF THE SAME MODEL AND EVERYTHING WORKED PROPERLY. THERE WAS NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20046738 ↗
• MalfunctionJul 22, 2024Vibration; Vibration

  IT WAS REPORTED THAT DURING PRE OP THE BLADE WAS BENT. THERE WAS NO PATIENT IMPACT. ANALYSIS CONFIRMED THAT THE BLADE WAS WOBBLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19789506 ↗
• MalfunctionJun 10, 2024Break; Break

  IT WAS REPORTED THAT DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY, QUADCUT BLADE BROKE INTO TWO PIECES. PROCEDURE WAS COMPLETED WITH ANOTHER QUADCUT BLADE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19496581 ↗
• MalfunctionApr 29, 2024Vibration; Vibration

  IT WAS REPORTED THAT DURING FESS PROCEDURE THE BLADE SHAFT VIBRATES TOO MUCH TO DEBRIDE THE TISSUE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19200196 ↗
• MalfunctionFeb 13, 2024Break; Break

  IT WAS REPORTED THAT DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY, WHILE USING THE BLADE THE SURGEON NOTICED IT FELT DIFFERENT THAN USUAL SO HE TOOK THE BLADE OUT OF THE HANDPIECE & NOTED THE INNER CANNULA HAD SNAPPED OFF. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18695386 ↗
• MalfunctionSep 20, 2023Break; Break

  ANALYSIS CONFIRMED THAT THERE WAS NO BROKEN BLADE IN THE RETURNED PACKAGE. UPON FOLLOW-UP IT WAS REPORTED THAT THE BLADES WERE NOT WORKING PROPERLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17778644 ↗
• MalfunctionAug 29, 2023Vibration; Vibration

  IT WAS REPORTED THAT INTRA-OP DURING BILATERAL SINUS SURGERY, QUADCUT BLADE STARTED VIBRATION EXCESSIVELY. NURSE TRIED TO RESEAT THE BLADE MULTIPLE TIMES WITH NO LUCK. ANOTHER QUADCUT BLADE WAS OPENED AND THERE WERE NO FURTHER ISSUES. THE PROCEDURE WAS DELAYED BY 5 MINUTES. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17640999 ↗
• MalfunctionMar 20, 2023Break; Break

  IT WAS REPORTED BY HEALTH CARE PROFESSIONAL THAT DURING OPERATION BLADE NOT ENGAGING THEN STOPPED TURNING WHILE DISMANTLING INNER BLADE WAS FOUND BROKEN. IT WAS FURTHER REPORTED THE BLADE WAS CHANGED AND IT WORKED FINE. THERE WAS NO REPORTED PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED THAT THE BLADE BROKEN NOTICED WHEN IT STOPPED OSCILLATING WHILE IN USE BUT DIDN¿T ACTUALLY NOTICE BROKEN UNTIL REMOVED IT FROM HANDPIECE. THEY WERE NOT AWARE IF ANY FRAGMENTS/PIECES DETACH FROM THE BROKEN DEVICE. IT LOOKED LIKE A CLEAN BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16579856 ↗
• MalfunctionMar 10, 2022Vibration; Vibration

  HEALTHCARE PROFESSIONAL REPORTED THAT DURING ENDOSCOPIC SINUS SURGERY, WHEN IN USE THE BLADE WOBBLED. THEY OPENED ANOTHER HANDPIECE TO TRY BUT HAD THE SAME RESULT. THEN THEY OPENED ANOTHER PACKAGE OF THE SAME BLADE AND IT WORKED PROPERLY. NO BROKEN PIECES OF THE REPORTED PRODUCT REMAIN INSIDE THE PATIENT'S BODY. THERE WAS A DELAY OF 5 MINS AND NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED THAT THE SURGEON STARTED THE SURGERY WITH THE AFFECTED BLADE, BLADE WAS USED FOR FIRST TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13717655 ↗
• MalfunctionMar 11, 2019Vibration; Vibration

  ADDITIONAL INFORMATION FROM A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE EVENT OCCURRED DURING AN ENDOSCOPIC SINUS SURGERY PROCEDURE. THERE WAS A SLIGHT DELAY TO GET ANOTHER HANDPIECE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8409936 ↗
• MalfunctionMar 11, 2019Vibration; Vibration

  ADDITIONAL INFORMATION FROM A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE EVENT OCCURRED DURING AN ENDOSCOPIC SINUS SURGERY PROCEDURE. THERE WAS A SLIGHT DELAY TO GET ANOTHER HANDPIECE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8409910 ↗
• MalfunctionOct 30, 2018Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT WHEN THE SCRUB TECH TRIED TO PULL APART THE STRAIGHT BLADE TO CLEAN IT, THE BASE SNAPPED OFF. THE FUNCTIONAL ENDOSCOPIC SINUS SURGERY WAS ON HOLD FOR TWO MINUTES WHILE THEY OPENED A NEW BLADE. THERE WERE NO BROKEN PIECES LEFT INSIDE THE PATIENT'S BODY. THERE WAS NO ISSUE TO THE PATIENT AND THE SURGERY WAS RESOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8019161 ↗